Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Surgical support tape, non-bioabsorbable FDA UDI
Device Name: Radiopaque FiberTape Sternal w/Blunt NDL FDA UDI
Model / Reference: AR-7289R FDA UDI
Description: Radiopaque FiberTape Sternal w/Blunt NDL FDA UDI

Identifiers

Catalog Number: AR-7289R FDA UDI
Primary DI / UDI-DI: 00888867392045 FDA UDI
FDA Product Code: GAT FDA UDI
JDQ FDA UDI
GMDN Term: Surgical support tape, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5000 FDA UDI
888.3010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical support tape, non-bioabsorbable

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical support tape, non-bioabsorbable.

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Stitch Cerclage - Suture Tapes — GM DOS REIS INDUSTRIA E COMERCIO LTDA · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI 125ab3d7-843d-4cd5-ae17-226d41f4406a 35 fields · synced Jun 6, 2026